Structure/Function Claims
RegulatoryAlso known as: S/F claims, Structure function claims, Dietary supplement claims
Claims about how a supplement affects body structure or function, allowed without FDA pre-approval.
What It Means
Structure/function claims describe the role of a nutrient or dietary ingredient in affecting the structure or function of the body (e.g., 'calcium builds strong bones,' 'supports immune health'). Under DSHEA, these claims do not require FDA pre-approval but must: (1) be truthful and not misleading, (2) include the disclaimer 'This statement has not been evaluated by the FDA...', (3) not claim to diagnose, treat, cure, or prevent disease, and (4) be notified to FDA within 30 days of first use.
What It Is Not
Structure/function claims are NOT health claims or drug claims. 'Supports immune health' (structure/function) is legally different from 'prevents colds' (drug claim). The line between them is frequently litigated and not always clear. FDA can take enforcement action against claims that cross into drug territory.
Evidence and References
- legislationDSHEA Section 6
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